A recent study published in Cell Reports Medicine has shown that 300 mg of Vitamin E daily can significantly improve liver health in patients suffering from Metabolic Dysfunction-Associated Steatohepatitis (MASH). The study, which lasted 96 weeks, found that Vitamin E supplementation resulted in reduced liver inflammation and improvements in liver histology, without significant safety concerns.
Background
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), affecting nearly 30% of the global population, has become a silent health crisis. Its more severe form, MASH, is marked by liver damage, inflammation, and fibrosis. Despite lifestyle changes, effective pharmacological treatments for MASH remain limited, with resmetirom recently approved for certain patients with fibrotic MASH. Researchers have been investigating Vitamin E, a natural antioxidant, as a potential treatment to alleviate liver inflammation, though its optimal dosage, long-term effects, and safety have been under scrutiny.
About the Study
This multi-center, double-blind, randomized, placebo-controlled trial involved 124 participants from 14 clinical centers in China. All participants were diagnosed with biopsy-confirmed MASH and were randomly assigned to either the Vitamin E (300 mg/day) or placebo group. Baseline and post-treatment liver biopsies were reviewed by independent pathologists. The primary endpoint was histological improvement, defined as a decrease in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) by at least two points, without worsening fibrosis.
The study also assessed secondary endpoints including fibrosis regression, resolution of steatohepatitis, changes in liver enzymes, inflammatory markers, and metabolic parameters. Liver stiffness measurements using FibroScan were also performed to evaluate potential fibrosis progression.
Study Results
The Vitamin E group, consisting of 58 participants, showed significant histological improvement with 29.3% of participants experiencing a reduction in NAS, compared to just 14.1% in the placebo group. This finding was statistically significant (odds ratio [OR]: 2.5; 95% CI: 1.0-7.1; p = 0.04). Furthermore, liver stiffness was notably improved in the Vitamin E group (p = 0.04), indicating potential long-term benefits for fibrosis, even though biopsy results did not show statistically significant differences in fibrosis regression.
Despite improvements in liver function, the resolution of steatohepatitis did not differ significantly between the two groups. However, Vitamin E treatment did lead to meaningful reductions in steatosis, lobular inflammation, fibrosis score, and the total NAS score. Liver enzyme levels, including ALT and AST, dropped by 20% and 18%, respectively, in the Vitamin E group. Pro-inflammatory cytokines, including TNF-α and IL-6, also showed significant reductions, with IL-6 levels decreasing (p = 0.04).
Safety and Additional Findings
The Vitamin E treatment was generally well-tolerated, with minimal adverse effects. The most common issues were mild gastrointestinal symptoms, reported by 12% of those in the Vitamin E group, compared to 6% in the placebo group. Notably, there were no reports of prostate cancer, cardiovascular events, or hemorrhagic stroke, which had been concerns in previous high-dose Vitamin E studies.
Exploratory analyses suggested that Vitamin E might also improve certain metabolic parameters, including insulin sensitivity, though no significant differences in lipid profiles or body mass index (BMI) were observed. Additionally, genetic analysis revealed a potential link between the HP 2-2 haptoglobin genotype and Vitamin E responsiveness, though further research is needed to confirm this finding.
Conclusion
This study supports the potential of 300 mg of Vitamin E as a viable treatment for MASH, showing significant improvements in liver histology and inflammation markers. While fibrosis regression did not reach statistical significance, the overall results indicate that Vitamin E could offer long-term benefits in managing liver disease. Importantly, the treatment was safe, with no significant adverse effects. These findings could pave the way for non-invasive, accessible treatment options for patients suffering from MASH, potentially reducing the global burden of liver disease.
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